Lundbeck (Deerfield, IL) issued a voluntary recall of its anti-inflammatory drug NeoProfen (ibuprofen lysine) Injection last Friday because it contains visible particulates, according to a company press release. The recall will cause a temporary shortage of the drug because the company recalled both lots that are currently available to prescribers. The recall includes product lots 1734991 (expiration date: April, 2011) and 1922319 (expiration date: March, 2012).
NeoProfen is a nonsteroidal, anti-inflammatory therapy administered to premature infants with a heart condition known as a patent ductus arteriosus (PDA), in which a blood vessel in the heart that normally closes at birth instead remains open, causing too much blood to flow to the lungs. NeoProfen is to treat premature babies with a PDA who weigh between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective, according to Lundbeck’s recall notice.
The recall was issued as a precautionary measure, and Lundbeck said it had not received reports of adverse events due to the particulates in the affected lots. “The potential adverse events resulting from the use of a sterile injectable product with particulates can be very serious and potentially fatal,” said the company in its recall notice. Risks of particulate matter in the medication include the potential to obstruct blood vessels (which could induce pulmonary emboli or activate platelets and/or neutrophils to induce anaphylactic reactions) and particulates in an intravenous injection could cause foreign body granulomas and local irritation of blood vessels, according to the notice.
Lundbeck stated that it advised the US Food and Drug Administration of the recall and notified wholesalers, hospital pharmacies, and prescribing neonatologists of the recall and product shortage. Given the vulnerable heath of the population treated with a drug such as NeoProfen, it is vital that a drug manufacturer communicate quickly and effectively about a recall—especially in the event of a suspected quality issue.